US Environmental Protection Agency
Office of Pesticide Programs
Spirotetramat - Notice of Cancellation Order;
Opportunity for Public Comment

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Spirotetramat - Notice of Cancellation Order; Opportunity for Public Comment
Summary
This notice announces the Agency's intent to issue a cancellation order for the pesticide
spirotetramat pursuant to section 6(a)(1) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), 7 U.S.C. 136d(a)(l), and the opening of a comment period on the existing stocks
provisions of such cancellation order. Comments must be received on or before February 8,
2010.
On December 23, 2010, the U.S. District Court for the Southern District of New York
vacated all registrations issued by EPA for pesticide products containing the active ingredient
spirotetramat. The basis for the Court's decision was EPA's failure to provide an opportunity for
comment on the applications for those registrations before the Agency granted them. The vacatur
is currently stayed until February 16, 2010; when the stay is lifted, the spirotetramat registrations
will cease to be valid under FIFRA. When that happens, EPA intends to issue a cancellation
order that will establish provisions governing the disposition of existing stocks of previously-
registered spirotetramat pesticide product already in the channels of trade (e.g., in the hands of
wholesalers, retailers, and users). EPA is providing an opportunity for interested parties to
comment on how they believe EPA should treat the sale, distribution, and/or use of existing
stocks of spirotetramat in the cancellation order.
Due to the short time before vacatur of the registrations will take effect, EPA is
publishing this notice on its website rather than through publication in the Federal Register, and
comments must be received by February 8, 2010.
How to Submit comments; Agency contact.
Interested parties may submit comments, on or before February 8, 2010, by email to
Meredith Laws at: Laws.Meredith@epa.gov. Because of the need to consider the comments
quickly in order to issue a cancellation order as early as February 16, 2010, EPA requests that
commenters not submit any material that must be treated as confidential business information
(CBI). If a commenter finds it essential to submit a comment that contains CBI, the commenter
should contact Meredith Laws by email, or by phone at (703) 308-7038. Any other questions
should also be directed to Ms. Laws by email or phone.
Background
On October 10, 2006, EPA received applications from Bayer CropScience (Bayer) to
register three new pesticide products containing the active ingredient spirotetramat - a tetramic
acid derivative insecticide - under section 3 of FIFRA, 7 U.S.C. 136a, for use on a wide variety
of agricultural crops and on Christmas trees. On February 5, 2007, EPA received another
application from Bayer for a spirotetramat end-use product for insect control in greenhouses,
nurseries, and interior plantscapes. On April 27, 2007, EPA received an application from Bayer
for another spirotetramat end-use product for agricultural use.

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Although later vacated by court order (described below), the Agency approved the
applications for the technical and one end-use product on June 30, 2008, as Spirotetramat
Technical and Movento (EPA Registration Number 264-1049 and 264-1050, respectively) for
control of insects on several agricultural crops and Christmas trees. The Agency approved the
application for Spirotetramat 240 SC Greenhouse and Nursery (EPA Registration Number 432-
1471) on August 8, 2008 for insect control in greenhouses, nurseries, and interior plantscapes.
The Agency approved the application for BYI 8330 150 OD Insecticide (EPA Registration
Number 264-1051) on September 24, 2008 for control of insects on several agricultural crops
and Christmas tree plantations. The Agency approved the application for Ultor (EPA
Registration Number 264-1065) on December 16, 2008 for control of insects on several
agricultural crops and Christmas tree plantations.
On December 23, 2009, due to lack of publication of a notice of receipt of the
spirotetramat registration applications in the Federal Register under section 3(c)(4) of FIFRA,
the U.S. District Court for the Southern District of New York issued an order vacating the
spirotetramat registrations that the Agency issued in 2008, and remanding the matter to EPA for
further proceedings in accordance with FIFRA and the Administrative Procedure Act (APA).
See Natural Resources Defense Council, Inc. v. EPA, 2009 WL 5033959 (Dec. 23, 2009). The
vacatur is currently stayed until February 16, 2010. When the stay is lifted, the registrations will
no longer be in effect under FIFRA, and no new spirotetramat material can thereafter lawfully be
released for shipment by manufacturers unless and until new registrations are issued.
As a result of the Court's decision to vacate the registrations of the pesticide
spirotetramat due to EPA's failure to publish a notice of receipt of the registrations for public
comment, EPA intends to treat Bayer's earlier-filed applications for registration as now pending
before the Agency. Although EPA commenced a comment period on these applications on
August 6, 2009 (74 Fed. Reg. 39321), the Court determined that this was not adequate to correct
the original deficiency. Therefore, the Agency intends to publish a new notice for comment in
the Federal Register in the next few weeks. EPA will consider the comments filed in 2009 in
this comment period, as well as any new or additional comments submitted in response to this
new notice, and will then determine whether the spirotetramat applications for registration
should be granted and, if so, what license conditions and label language would be appropriate
under FIFRA.
Existing Stocks Questions to be Addressed
While the Court determined that the registrations should not be allowed to continue
unless and until EPA makes a decision on the registration following the process set forth in
section 3(c)(4) of FIFRA (7 U.S.C. §136a(c)(4)), the question of what should happen to existing
stocks of spirotetramat that are already in the channels of trade {i.e., material that has been
released for shipment and is in the hands of sellers, distributors, or users) at the time the
registrations terminate due to the vacatur was not before the court. In the absence of any action
by EPA, all sale and distribution of formerly-registered spriotetramat products will be unlawful
under FIFRA once the vacatur goes into effect. The term "distribute or sell" is defined very
broadly in FIFRA section 2(gg) (7 U.S.C. §136(gg)), and includes, among other things, any

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"shipment" of unregistered pesticide. Without action by EPA, the termination of the
registrations could thus make illegal not just any sale, but any further movement of material
currently in the hands of distributors or retailers (FIFRA section 12(a)(1)(A) (7 U.S.C.
§136(j)(a)(l)(A)) makes it a violation of FIFRA for any person to sell or distribute an
unregistered pesticide), and subject any seller/distributor to potential civil or criminal penalties
under FIFRA section 14 (7 U.S.C. §1361).
There is no corresponding provision of FIFRA that prohibits use (as opposed to
distribution or sale) of unregistered pesticides (see FIFRA section 12 (7 U.S.C. §136j)).
Furthermore, section 12(a)(2)(G) (7 U.S.C. §136j (a)(2)(G)) only makes it a violation of FIFRA
for any person to "use any registered pesticide in a manner inconsistent with its labeling"
(emphases added); there is no provision that requires that unregistered pesticides (including
formerly-registered pesticides) be used according to their labels. Thus, in the absence of EPA
action, users of unregistered pesticides are not obligated to follow the labeling (which, for
registered pesticides, prescribes enforceable conditions for using the particular pesticide, among
other things) accompanying the product. Therefore, once the registrations are terminated, unless
EPA takes action, persons holding stocks of spirotetramat will not be legally precluded from
using those stocks without following label directions, including the restrictions on timing of
applications that EPA required in order to protect bees.
FIFRA contains a provision that allows EPA to issue enforceable orders governing the
sale, distribution, and use of existing stocks of cancelled pesticides. Specifically, section 6(a)(1)
of FIFRA (7 U.S.C. §136d(a)(l)) provides that: "The Administrator may permit the continued
sale and use of existing stocks of a pesticide whose registration is suspended or canceled under
[sections 3, 4 or 6 of FIFRA] to such extent, under such conditions, and for such uses as the
Administrator determines that such sale or use is not inconsistent with the purposes of [FIFRA] "
Section 12(a)(2)(K) of FIFRA (7 U.S.C. §136j(a)(2)(K)) makes the failure to comply with a
cancellation order enforceable under FIFRA. Whenever EPA cancels a registration, it issues
such a cancellation order establishing enforceable provisions concerning the disposition of
existing stocks. Such orders can authorize sale or distribution that would otherwise be unlawful,
and they can prohibit use that would otherwise be lawful. They can also contain limitations or
conditions on the sale, distribution, or use that the Administrator determines to be appropriate;
one such limitation that EPA frequently applies to existing stocks is a condition that any
authorization of use of such stocks is limited to use that is consistent with the previously-
approved labeling accompanying the product.
In the case of spirotetramat, the registrations are being vacated by court order, rather than
cancelled by EPA itself. Nonetheless, the Agency believes that the Court's action in vacating the
spirotetramat registrations is best viewed under FIFRA as a cancellation of those registrations
under section 3 (because the vacatur is based upon the Agency's failure to comply with the
requirements of section 3 of FIFRA). See Termilind Limited; Notice and Order of Revocation of
Registrations, 62 Fed. Reg. 61890, 61894 (Nov. 19, 1997) ("The Agency has concluded that
there is no meaningful distinction between a revocation and a cancellation, and that the
revocation of Termilind's registration was a cancellation under section 3 giving the Agency
authority over the sale and use of existing stocks."). The Agency therefore intends to issue a

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cancellation order under FIFRA section 6(a)(1) that will establish provisions governing the
disposition of existing stocks of previously-registered spirotetramat pesticide product.
While EPA is not obligated to take public comment on the contents of cancellation
orders, the Agency believes that public input in this particular circumstance could be beneficial.
EPA is therefore initiating this public comment period to seek input from interested parties on
how they believe EPA should treat existing stocks of spirotetramat in a cancellation order. The
Agency would like to have the cancellation order ready to take effect when the registrations
cease to exist (February 16, 2010 unless the stay is extended), and therefore EPA believes a
shortened comment period is necessary in order to allow the Agency to consider the comments
before February 16th.
EPA issued in 1991 a policy statement outlining the considerations it generally applies in
determining how to treat existing stocks in cancellation orders. See 56 Fed. Reg. 29362 (June
26, 1991). Regarding cancelled pesticides, the existing stocks policy identifies particular
considerations relevant to five different cancellation scenarios: 1) cancellations where the
Agency has identified particular risk concerns; 2) cancellations where a registrant has failed to
comply with an obligation of registration; 3) cancellation of products while subject to data call-in
notices under section 3(c)(2)(B) of FIFRA; 4) cancellation of registrations subject to
reregi strati on requirements and label improvement programs; and 5) other voluntary
cancellations.
In general, if the Agency has no significant risk concerns associated with a cancelled
product, the policy statement suggests that the Agency will generally allow unlimited use of
existing stocks, and unlimited sale by persons other than the registrant. A registrant will
generally be allowed to continue to sell existing stocks for 1 year after the date cancellation is
requested, or 1 year after the date the registrant has ceased to comply with the responsibilities
that are placed upon registrants, whichever date is sooner. 56 Fed. Reg. at 29362, 29364.
If there are significant risk concerns associated with a cancelled pesticide, the
policy statement states that the Agency will generally make a case-by-case determination
as to whether to allow the continued sale or use of existing stocks of the pesticide. That
determination, like the initial decision to register a pesticide, will focus on the social,
economic, and environmental risks and benefits associated with such sale and use. But
while the registration decision focuses almost exclusively on the risks and benefits
associated with the use of the pesticide, the existing stocks determination is somewhat
different because it focuses on product already manufactured and (in many cases) sold to
others. Thus, EPA identified in the policy statement six criteria it might consider in
making such risk benefit decisions, including: 1) the quantity of existing stocks at each
level of the channels of trade; 2) the risks resulting from the use of the existing stocks; 3)
the benefits resulting from the use of such stocks; 4) the financial expenditures users and
others have already spent on existing stocks; 5) the risks and costs of disposal or
alternative disposition of the stocks; and 6) the practicality of implementing restrictions
on distribution, sale, or use of the existing stocks. 56 Fed. Reg. at 29364^

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The Agency believes the criteria outlined in the existing stocks policy are generally
appropriate for use in existing stocks situations, and may well be appropriate for use in the case
of spirotetramat. However, EPA is also mindful of the fact that spirotetramat is a novel situation
different from any the Agency has confronted in the nearly twenty years since the development
of the policy statement. While commenters may wish to consider the 1991 policy statement as a
starting point for determining what issues to address in their comments, commenters should feel
free to raise any issue they believe would be pertinent to the disposition of existing stocks of
spirotetramat products after February 16, 2010.

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